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Prevention of Cisplatin-induced Nephrotoxicity

StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 7, 2025 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Sep 30, 2025 to Sep 30, 2026 Start date: Apr 1, 2024 to Dec 1, 2025 · Primary endpoints: 2 to 1 · Secondary endpoints: details revised at 1 of 1 entryv2 Show 3 more changesShow less
    • Start date: Apr 1, 2024 to Dec 1, 2025
    • Primary endpoints: 2 to 1
    • Secondary endpoints: details revised at 1 of 1 entry

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The research design is a prospective, randomized, controlled clinical trial in children to study effect of aminophylline in preserving renal function in oncologic patient received cisplatin either combined with other CMT or used alone. The participants in both groups will receive standard protocol pre-cisplatin infusion which include hydration with 5%DNSS/2 with KCL and MgSO4 IV infusion. In the treatment group, the participants will receive aminophylline infusion in the first 24 hours along with cisplatin, followed by oral aminophylline oral three times daily orally for 4 consecutive days post cisplatin. The aminophylline serum level will be maintained at the therapeutic range 10-20 mg. The side effect of aminophylline including nausea, vomiting and ECG will be monitored. The collected data including urine volume, GFR (estimated by cystatin C-creatinine based equation and by radiopharmaceutical-Tc DTPA), and renal tubular biomarker (urine B2 macroglobulin and urine NGAL) will be collected at baseline before receiving cisplatin, 24 hours and 5 days post cisplatin.
Trial Details
NCT Number NCT06196853
Lead Sponsor Mahidol University
Conditions Acute Kidney Injury, Renal Tubulopathy
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov